Fish and Fishery Products Hazards and Controls Guidance Chapter 13

CHAPTER 13: Clostridium botulinum Toxin Formation
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not
create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an
alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want
to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot
identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.
UNDERSTAND THE POTENTIAL HAZARD. • Controlling the amount of moisture that is

available for pathogenic bacteria growth
Clostridium botulinum (C. botulinum) toxin (water activity) in the product by formulation
formation can result in consumer illness and (covered in this chapter);
death. It is the toxin responsible for botulism. • Controlling the amount of moisture that is
About 10 outbreaks of foodborne botulism occur available for pathogenic bacteria growth
annually in the United States, from all sources. (water activity) in the product by drying
Symptoms include: weakness, vertigo, double (covered in Chapter 14);
vision, difficulty in speaking, swallowing and • Controlling the introduction of pathogenic
breathing, abdominal swelling, constipation, bacteria after the pasteurization process
paralysis, and death. Symptoms start from 18 and after the cooking process performed
hours to 36 hours after consumption. Everyone immediately before reduced oxygen packaging
is susceptible to intoxication by C. botulinum (covered in Chapter 18);
toxin; only a few micrograms of the toxin can • Controlling the source of molluscan shellfish
cause illness in a healthy adult. Mortality is high; and the time from exposure to air (e.g., by
without the antitoxin and respiratory support, harvest or receding tide) to refrigeration
death is likely. to control pathogens from the harvest area
This chapter covers the hazard of C. botulinum (covered in Chapter 4);
growth and toxin formation as a result of time and • Managing the amount of time that food is
temperature abuse during processing, storage, and exposed to temperatures that are favorable
distribution. for pathogenic bacteria growth and toxin
production (covered generally in Chapter
• Strategies for controlling pathogen growth
12; for C. botulinum, in this chapter; and for
There are a number of strategies for the control Staphylococcus aureus (S. aureus) in hydrated
of pathogens in fish and fishery products. They batter mixes, in Chapter 15);
include:
• Killing pathogenic bacteria by cooking or
• Controlling the level of acidity (pH) in the pasteurization (covered in Chapter 16), or
product (covered by the Acidified Foods retorting (covered by the Thermally Processed
regulation, 21 CFR 114, for shelf-stable Low-Acid Foods Packaged in Hermetically
acidified products, and by this chapter for Sealed Containers regulation, 21 CFR 113
refrigerated acidified products); (hereinafter, the Low-Acid Canned Foods
• Controlling the amount of salt or (LACF) Regulation));
preservatives, such as sodium nitrite, in the • Killing pathogenic bacteria by processes that
product (covered in this chapter); retain the raw product characteristics (covered
in Chapter 17).
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• Formation of C. botulinum toxin packaging and modified atmosphere packaging)
When C. botulinum grows, it can produce a extend the shelf life of a product by inhibiting
potent toxin, one of the most poisonous naturally the growth of aerobic spoilage bacteria. There
occurring substances known. The toxin can be is a safety concern with these products because
destroyed by heat (e.g., boiling for 10 minutes), there is an increased potential for the formation
but, because of its potency, you should not rely of C. botulinum toxin before spoilage makes the
on this as a means of control. product unacceptable to consumers.
The strains of C. botulinum can be divided C. botulinum forms toxin more rapidly at higher
into two groups, the proteolytic group (i.e., temperatures than at lower temperatures. The
those that break down proteins) and the non minimum temperature for growth and toxin
proteolytic group (i.e., those that do not break formation by C. botulinum type E and non
down proteins). The proteolytic group includes proteolytic types B and F is 38°F (3.3°C). For
C. botulinum type A and some of types B and F. type A and proteolytic types B and F, the
The non-proteolytic group includes C. botulinum minimum temperature for growth is 50°F (10°C).
type E and some of types B and F. As the shelf life of refrigerated foods is increased,
more time is available for C. botulinum growth
The vegetative cells of all types of C. botulinum
and toxin formation. As storage temperatures
are easily killed by heat. However, C. botulinum
increase, the time required for toxin formation is
is able to produce spores. In this state, the
significantly shortened. You should expect that at
pathogen is very resistant to heat. The spores
some point during storage, distribution, display,
of the proteolytic group are much more resistant
or consumer handling of refrigerated foods, safe
to heat than are those of the non-proteolytic
refrigeration temperatures will not be maintained
group (i.e., they require a canning process to be
(especially for the non-proteolytic group). Surveys
destroyed). Table A-4 (Appendix 4) provides
of retail display cases indicate that temperatures
guidance about the conditions under which
of 45 to 50°F (7 to 10°C) are not uncommon.
the spores of the most heat-resistant form
Surveys of home refrigerators indicate that
of non-proteolytic C. botulinum, type B, are
temperatures can exceed 50°F (10°C).
killed. However, there are some indications
that substances that may be naturally present In reduced oxygen packaged products in which
in some products (e.g., dungeness crabmeat), the spores of non-proteolytic C. botulinum
such as lysozyme, may enable non-proteolytic are inhibited or destroyed (e.g., smoked fish,
C. botulinum to more easily recover after heat pasteurized crabmeat, and pasteurized surimi),
damage, resulting in the need for a considerably a normal refrigeration temperature of 40°F
more stringent process to ensure destruction. (4.4°C) is appropriate because it will limit
the growth of proteolytic C. botulinum and
C. botulinum is able to produce toxin when
other pathogens that may be present. Even
a product in which it is present is exposed to
in pasteurized products where non-proteolytic
temperatures favorable for growth for sufficient
C. botulinum is the target organism for the
time. Table A-1 (Appendix 4) provides guidance
pasteurization process, and vegetative pathogens,
about the conditions under which C. botulinum
such as Listeria monocytogenes, are not likely
and other pathogenic bacteria are able to grow.
to be present (e.g., pasteurized crabmeat and
Table A-2 (Appendix 4) provides guidance about
pasteurized surimi), a storage temperature of
the time necessary at various temperatures for
40°F (4.4°C) is still appropriate because of the
toxin formation to occur.
potential for survival through the pasteurization
Packaging conditions that reduce the amount process and recovery of spores of non-proteolytic
of oxygen present in the package (e.g., vacuum C. botulinum, aided by naturally occurring
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substances, such as lysozyme. In this case, toxin formation in reduced oxygen packaged fish
refrigeration serves as a prudent second barrier. and fishery products.
However, in reduced oxygen packaged products Alternatively, products of this type may be safely
in which refrigeration is the sole barrier to marketed frozen, with appropriate labeling
outgrowth of non-proteolytic C. botulinum and to ensure that it is held frozen throughout
the spores have not been destroyed (e.g., vacuum- distribution. For some reduced oxygen packaged
packaged refrigerated raw fish, vacuum-packaged products, control of C. botulinum can be
refrigerated unpasteurized crayfish meat, and achieved by breaking the vacuum seal before the
reduced oxygen packaged unpasteurized product leaves the processor’s control.
dungeness crabmeat), the temperature should be
The guidance in this chapter emphasizes
maintained below 38°F (3.3°C) from packing to
consumption. Ordinarily you, as a processor, can preventive measures for the control of non
ensure that temperatures are maintained below proteolytic strains of C. botulinum in products
38°F (3.3°C) while the product is in your control. that are contained in reduced oxygen packaging.
However, the current U.S. food distribution As was previously described, this emphasis
system does not ensure the maintenance of these is because such an environment extends the
temperatures after the product leaves your control. shelf life of a refrigerated product in a way that,
under moderate temperature abuse, favors C.
The use of a Time-Temperature Indicator (TTI) on botulinum growth and toxin formation over
each consumer package may be an appropriate aerobic spoilage. It is also possible for both
means of overcoming these problems in the non-proteolytic and proteolytic C. botulinum
distribution system for reduced oxygen packaged to grow and produce toxin in a product that is
products in which refrigeration is the sole barrier not reduced oxygen packaged and is subjected
to outgrowth of non-proteolytic C. botulinum and to severe temperature abuse. This is the case
in which the spores have not been destroyed.
because of the development within the product
A TTI is a device that monitors the time and
of microenvironments that support its growth.
temperature of exposure of the package and
However, this type of severe temperature abuse
alerts the consumer or end user if a safe exposure
of refrigerated products is not reasonably likely
limit has been exceeded. If a TTI is used, it
to occur in the processing environment of most
should be validated to ensure that it is fit for its
fish or fishery products and the Current Good
intended purpose and verified that it is functional
Manufacturing Practice in Manufacturing, Packing,
at the time of use. It should be designed to alert
or Holding Human Food regulation, 21 CFR 110,
the consumer (e.g., a color change) that an unsafe
requires refrigeration of foods that support the
time and temperature exposure has occurred
growth of pathogenic microorganisms.
that may result in C. botulinum toxin formation.
Additionally, the alert should remain perpetually • Sources of C. botulinum
visible after it has been triggered, regardless of
C. botulinum can enter the process on raw
environmental conditions that could reasonably
materials. The spores of C. botulinum are very
be expected to occur thereafter. Skinner, G. E.,
common. They have been found in the gills
and J. W. Larkin in “Conservative prediction of
and viscera of finfish, crabs, and shellfish. C.
time to Clostridium botulinum toxin formation for
botulinum type E is the most common form found
use with time-temperature indicators to ensure
in freshwater and marine environments. Types
the safety of foods,” Journal of Food Protection,
A and B are generally found on land but may
61:1154-1160 (1998), describe a safe time and
temperature exposure curve (“Skinner-Larkin also be occasionally found in water. It should be
curve”) that may be useful in evaluating the assumed that C. botulinum will be present in any
suitability of a TTI for control of C. botulinum raw fishery product, particularly in the viscera.
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Because spores are known to be present in the packaging) may be rapidly depleted by the
viscera, any product that will be preserved by activity of spoilage bacteria, resulting in the
salting, drying, pickling, or fermentation should formation of a reduced oxygen environment.
be eviscerated prior to processing (see the
Packaging that provides an oxygen transmission
“Compliance Policy Guide,” Sec. 540.650). Without
rate (in the final package) of at least 10,000 cc/
evisceration, toxin formation is possible during the
m2/24 hours at 24ºC can be regarded as an
process, even with strict control of temperature.
oxygen-permeable packaging material for fishery
Evisceration of fish is the careful and complete
products. The oxygen transmission rate of
removal of all internal organs in the body cavity
packaging material is listed in the packaging
without puncturing or cutting them, including
specifications that can be obtained from the
gonads. If even a portion of the viscera or its
packaging manufacturer.
contents is left behind, the risk of toxin formation
by C. botulinum remains. Uneviscerated small An oxygen-permeable package should provide
fish, less than 5 inches in length (e.g., anchovies sufficient exchange of oxygen to allow aerobic
and herring sprats), for which processing eliminates spoilage organisms to grow and spoil the product
preformed toxin, prevents toxin formation during before toxin is produced under moderate abuse
processing and that reach a water phase salt temperatures. Particular care should be taken in
content of 10% in refrigerated finished products, determining the safety of a packaging material for a
or a water activity of below 0.85 in shelf-stable product in which the spoilage organisms have been
finished products, or a pH of 4.6 or less in shelf- eliminated or significantly reduced by processes
stable finished products, are not subject to the such as high pressure processing. The generally
evisceration recommendation. recommended 10,000 cc/m2/24 hours at 24ºC
Note: The water phase salt content of 10% is based on the control of
transmission rate may not be suitable in this case.
C. botulinum type A and proteolytic types B and F.
Use of an oxygen-permeable package may not
Note: The water activity value of below 0.85 is based on the compensate for the restriction to oxygen exchange
minimum water activity for toxin production of S. aureus.
created by practices such as packing in oil or in
• Reduced oxygen packaging deep containers from which the air is expressed
or the use of oxygen scavengers in the packaging.
A number of conditions can result in the creation
of a reduced oxygen environment in packaged • Control of C. botulinum
fish and fishery products. They include: There are a number of strategies to prevent C.
• Vacuum, modified, or controlled atmosphere botulinum growth and toxin formation during
packaging. These packaging methods processing, storage, and distribution of finished
generally directly reduce the amount of fish and fishery products. They include:
oxygen in the package;
For products that do not require refrigeration
• Packaging in hermetically sealed containers (i.e., shelf-stable products):
(e.g., double-seamed cans, glass jars
• Heating the finished product in its final
with sealed lids, and heat-sealed plastic
container sufficiently by retorting to destroy
containers), or packing in deep containers
the spores of C. botulinum types A B, E,
from which the air is expressed (e.g., caviar
and F (e.g., canned fish). This strategy is
in large containers), or packing in oil. These
covered by the LACF Regulation, 21 CFR
and similar processing and packaging
113, and these controls are not required to
techniques prevent the entry of oxygen into
be included in your Hazard Analysis Critical
the container. Any oxygen present at the
Control Point (HACCP) plan;
time of packaging (including oxygen that
may be added during modified atmosphere
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• Controlling the level of acidity (pH) in the • Controlling the amount of salt in the product
finished product to 4.6 or below, to prevent to 20% water phase salt (wps) or more, to
growth and toxin formation by C. botulinum prevent the growth of C. botulinum types A,
types A, B, E, and F (e.g., shelf-stable B, E, and F and other pathogens that may
acidified products). This strategy is covered be present in the product (e.g., shelf-stable
by the Acidified Foods regulation, 21 CFR salted products). This strategy is covered
114, and these controls are not required to be in this chapter. Water phase salt is the
included in your HACCP plan; concentration of salt in the water-portion of
• Controlling the amount of moisture that is the fish flesh and calculated as follows: (%
available in the product (water activity) to NaCl X 100)/(% NaCl + % moisture) = % NaCl
0.85 or below by drying, to prevent growth in water phase. The relationship between
and toxin formation by C. botulinum types percent water phase salt and water activity in
A, B, E, and F and other pathogens that may fish is described in the following graph.
be present in the product (e.g., shelf-stable
dried products). This strategy is covered by
Chapter 14;
Relationship of Water Activity to Water Phase

1
Salt in NaCl/Water Solutions
1.00
0.98
0.96
Water ac tivity
0.94
0.92
0.90
0.88
0.86
0.84
0 2 4 6 8 10 12 14 16 18 20
Percent water phase salt
1. This relationship is generally valid for fish products when salt (sodium chloride) is the primary means of
binding water. The specific food matrix and the use of other salts or water binding agents could affect the
exact relationship. If you intend to use this relationship in your control strategy, you should determine the
exact relationship in your product by conducting a study.
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For products that require refrigeration: type A and proteolytic types B and F and
• Heating the finished product in its final other pathogens that may be present in
container sufficiently by pasteurization to the finished product through refrigerated
destroy the spores of C. botulinum type storage (e.g., refrigerated dried fish). Drying
E and non-proteolytic types B and F, and is covered in Chapter 14, controlling the
then minimizing the risk of recontamination growth of proteolytic C. botulinum through
by controlling seam closures and cooling refrigeration is covered in this chapter, and
water, and next controlling the growth controlling the growth of other pathogenic
of the surviving C. botulinum type A and bacteria through refrigeration is covered in
proteolytic types B and F in the finished Chapter 12;
product with refrigerated storage (e.g.. • Controlling the level of pH to 5 or below, salt
pasteurized crabmeat and some pasteurized to 5% wps or more, moisture (water activity)
surimi-based products). Pasteurization to 0.97 or below, or some combination
is covered in Chapter 16, controlling of these barriers, in the finished product
recontamination after pasteurization is sufficiently to prevent the growth of C.
covered in Chapter 18, and controlling the botulinum type E and non-proteolytic
growth of proteolytic C. botulinum through types B and F by formulation, and then
refrigeration is covered in this chapter; controlling the growth of C. botulinum
• Heating the product sufficiently to destroy type A and proteolytic types B and F and
the spores of C. botulinum type E and other pathogens that may be present in
non-proteolytic types B and F, and then the finished product with refrigerated
minimizing the risk of recontamination storage (e.g., refrigerated acidified (pickled)
by hot filling the product into the final products). Controlling the growth of non-
container in a sanitary, continuous, closed proteolytic C. botulinum through formulation
filling system and controlling seam closures is covered in this chapter, controlling the
and cooling water, and next controlling growth of proteolytic C. botulinum through
the growth of the surviving C. botulinum refrigeration is covered in this chapter, and
type A and proteolytic types B and F and controlling the growth of other pathogenic
other pathogens that may be present in the bacteria through refrigeration is covered in
finished product with refrigerated storage Chapter 12;
(e.g., vacuum packed soups, chowders, and • Controlling the amount of salt and
sauces). Specialized cooking processes preservatives, such as sodium nitrite, in
are covered in Chapter 16, prevention of the finished product, in combination with
recontamination after specialized cooking other barriers, such as smoke, heat damage,
processes is covered in Chapter 18, and competitive bacteria, sufficiently to
controlling the growth of proteolytic C. prevent the growth of C. botulinum type
botulinum through refrigeration is covered E and non-proteolytic types B and F, and
in this chapter, and controlling the growth then controlling the growth of C. botulinum
of other pathogenic bacteria through type A and proteolytic types B and F and
refrigeration is covered in Chapter 12; other pathogens that may be present in the
• Controlling the amount of moisture that finished product with refrigerated storage
is available in the product (water activity) (e.g., salted, smoked, or smoke-flavored fish).
to 0.97 or below to inhibit the growth of Controlling the growth of non-proteolytic
C. botulinum type E and non-proteolytic C. botulinum through salting and smoking
types B and F by drying, and then is covered in this chapter, controlling the
controlling the growth of C. botulinum growth of proteolytic C. botulinum through
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refrigeration is covered in this chapter, and In hot-smoked products, heat damage to
controlling the growth of other pathogenic the spores of C. botulinum type E and non
bacteria through refrigeration is covered in proteolytic types B and F also helps prevent
Chapter 12; toxin formation. In these products, control of
• Controlling the amount of salt in the the heating process is critical to the safety of
finished product, in combination with heat the finished product. It is important to note,
damage from pasteurization in the finished however, that this same heating process also
product container, sufficiently to prevent reduces the numbers of naturally occurring
the growth of C. botulinum type E and spoilage organisms. The spoilage organisms
nonproteolytic types B and F, and then would otherwise have competed with, and
controlling the growth of C. botulinum inhibited the growth of, C. botulinum.
type A and proteolytic types B and F and In cold-smoked fish, it is important that
other pathogens that may be present in the product does not receive so much heat
the finished product with refrigerated that the numbers of spoilage organisms
storage (e.g., some pasteurized surimi are significantly reduced. This is important
based products). Controlling the growth because spoilage organisms must be present
of non-proteolytic C. botulinum through to inhibit the growth and toxin formation
a combination of salt and heat damage of C. botulinum type E and non-proteolytic
is covered in this chapter, controlling the types B and F. This inhibition is important
growth of proteolytic C. botulinum through in cold-smoked fish because the heat applied
refrigeration is covered in this chapter, and during this process is not adequate to
controlling the growth of other pathogenic weaken the C. botulinum spores. Control
bacteria through refrigeration is covered in of the temperature during the cold-smoking
Chapter 12. process to ensure survival of the spoilage
Examples of C. botulinum control in specific organisms is, therefore, critical to the safety
products: of the finished product.
The interplay of these inhibitory effects
• Refrigerated (not frozen), reduced oxygen
(i.e., salt, temperature, smoke, and nitrite)
packaged smoked and smoke-flavored fish
is complex. Control of the brining or dry
Achieving the proper concentration of salting process is clearly critical to ensure that
salt and nitrite in the flesh of refrigerated, there is sufficient salt in the finished product.
reduced oxygen packaged smoked and However, preventing toxin formation by C.
smoke-flavored fish is necessary to prevent botulinum type E and non-proteolytic types
the formation of toxin by C. botulinum type B and F is made even more complex by the
E and non-proteolytic types B and F during fact that adequate salt levels are not usually
storage and distribution. Salt works along achieved during brining. Proper drying
with smoke and any nitrites that are added during smoking is also critical in order to
to prevent growth and toxin formation by C. achieve the finished product water phase
botulinum type E and non-proteolytic types salt level (i.e., the concentration of salt in
B and F. Note that nitrites should be used the water portion of the fish flesh) needed
only in salmon, sable, shad, chubs, and tuna, to inhibit growth and toxin formation by C.
according to 21 CFR 172.175 and 21 CFR botulinum.
172.177 , and should not exceed a level of
200 ppm in salmon, sable, shad, chubs and This chapter covers the control procedures
10 ppm in tuna. described above.
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You should ordinarily restrict brining, dry also serves as a prudent second barrier
salting, and smoking loads to single species because of the potential survival through
and to fish portions of approximately the pasteurization process and recovery of
uniform size. This restriction minimizes the spores of non-proteolytic C. botulinum, aided
complexity of controlling the operation. You by naturally occurring substances, such as
should treat brine to minimize microbial lysozyme. Cooking and pasteurization are
contamination or periodically replace it as a covered in Chapter 16, and controlling the
good manufacturing practice control. growth of C. botulinum through refrigeration
is covered in this chapter.
The combination of inhibitory effects that are
present in smoked and smoke-flavored fish In the second category of products, filling
are not adequate to prevent toxin formation the product into the final container while it is
by C. botulinum type A and proteolytic types still hot in a continuous, closed filling system
B and F. Strict refrigeration control (i.e., at (i.e., hot filling) is also critical to the safety of
or below 40°F (4.4°C)) during storage and the finished product because it minimizes the
distribution should be maintained to prevent risk of recontamination of the product with
growth and toxin formation by C. botulinum pathogens, including C. botulinum type E and
type A and proteolytic types B and F and non-proteolytic types B and F. This control
other pathogens that may be present in strategy applies to products such as soups,
these products. Controlling the growth of chowders, and sauces that are filled directly
proteolytic C. botulinum through refrigeration from the cooking kettle, where the risk of
is covered in this chapter, and controlling the recontamination is minimized. It may not
growth of other pathogenic bacteria through apply to products such as crabmeat, lobster
refrigeration is covered in Chapter 12. meat, or crayfish meat or to other products
that are handled between cooking and filling.
• Refrigerated (not frozen), reduced oxygen Control of hot filling is covered in Chapter 18.
packaged, pasteurized fishery products
Chapter 18 also covers other controls that
Refrigerated, reduced oxygen packaged,
may be necessary to prevent recontamination,
pasteurized fishery products fall into two
including controlling container sealing and
categories: (1) those which are pasteurized
controlling contamination of container
in the final container; and (2) those which
cooling water. These controls may be critical
are cooked in a kettle and then hot filled
to the safety of both categories of products.
into the final container in a continuous,
closed filling system (e.g., heat-and-fill Examples of properly pasteurized products
soups, chowders, and sauces). In both follow: fish and fishery products generally
cases, ordinarily the heating process should (e.g., surimi-based products, soups,
be sufficient to destroy the spores of C. or sauces) pasteurized to a minimum
botulinum type E and non-proteolytic types cumulative total lethality of F194°F (F90°C)
B and F. In neither case is it likely that = 10 minutes, where z = 12.6°F (7°C) for
the heating process will be sufficient to temperatures less than 194°F (90°C), and
destroy the spores of C. botulinum type A z = 18°F (10°C) for temperatures above
and proteolytic types B and F. Therefore, 194°F (90°C); blue crabmeat pasteurized
strict refrigeration control (i.e., at or below to a minimum cumulative total lethality of
40°F (4.4°C)) should be maintained during F185°F (F85°C) = 31 minutes, where z = 16°F
storage and distribution to prevent growth (9°C); and dungeness crabmeat pasteurized
and toxin formation by C. botulinum type A to a minimum cumulative total lethality of
and proteolytic types B and F. Refrigeration F194°F (F90°C) = 57 minutes, where z = 15.5°F
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(8.6°C). Equivalent processes at different • Adding sufficient acid to reduce
temperatures can be calculated using the z the acidity (pH) to 5.0 or below;
values provided.
• Reducing the amount of moisture
that is available for growth (water
EXAMPLES OF PROPERLY PASTEURIZED activity) to below 0.97 (e.g., by
PRODUCTS
adding salt or other substances that
PRODUCT
MINIMUM CUMULATIVE
Z VALUE
“bind” the available water); or
TOTAL LETHALITY
Fish and fishery F194°F (F90°C) = 10 minutes 12.6°F (7°C), for • Making a combination of salt, pH,
products temperatures and/or water activity adjustments
generally less than 194°F
(e.g., surimi (90°C) that, when combined, prevents the
based products, 18°F (10°C) for growth of C. botulinum type E and
soups, or temperatures
sauces) above 194°F
non-proteolytic types B and F (to be
(90°C) established by a scientific study).
Blue crabmeat F185°F (F85°C) = 31 minutes 16°F (9°C)
Much like smoked products, in some of these
Dungeness F194°F (F90°C) = 57 minutes 15.5°F (8.6°C)
crabmeat
products the interplay of these inhibitory
effects (i.e., salt, water activity, and pH) can
be complex. Control of the brining, pickling,
In some pasteurized surimi-based
or formulation steps is, therefore, critical to
products, salt, in combination with a milder
ensure that there are sufficient barriers in the
pasteurization process, in the finished product
finished product to prevent the growth and
container works to prevent growth and toxin
toxin formation of C. botulinum type E and
formation by C. botulinum type E and non
non-proteolytic types B and F during storage
proteolytic types B and F. An example of a
and distribution. These control procedures
properly pasteurized surimi-based product
are covered in this chapter.
in which 2.4% wps is present is one that has
been pasteurized at an internal temperature You should ordinarily restrict brining and
of 185°F (85°C) for at least 15 minutes. This pickling loads to single species and to fish
process may not be suitable for other types of portions of approximately uniform size.
products because of the unique formulation This restriction minimizes the complexity of
and processing involved in the manufacture of controlling the operation. You should treat
surimi-based products. brine to minimize microbial contamination
or periodically replace it as a good
• Refrigerated (not frozen), reduced oxygen manufacturing practice control.
packaged pickled fish, salted fish, caviar,
and similar products The controls discussed above are not
sufficient to prevent toxin formation by C.
In pickled fish, salted fish, caviar, and similar
botulinum type A and proteolytic types B
products that have not been preserved
and F. Strict refrigeration control (i.e., at
sufficiently for them to be shelf stable,
or below 40°F (4.4°C)) during storage and
growth and toxin formation by C. botulinum
distribution should, therefore, be maintained
type E and non-proteolytic types B and F is
to prevent growth and toxin formation by C.
controlled by one of the following:
botulinum type A and proteolytic types B and
• Adding sufficient salt to produce F and other pathogens that may be present
a water phase salt level (i.e., the in these products. Controlling the growth of
concentration of salt in the water proteolytic C. botulinum through refrigeration
portion of the fish flesh) of at least 5%; is covered in this chapter, and controlling the
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growth of other pathogenic bacteria through • Frozen, reduced oxygen packaged raw,
refrigeration is covered in Chapter 12. unpreserved fish and unpasteurized, cooked
fishery products
• Refrigerated (not frozen), reduced oxygen
For frozen, reduced oxygen packaged raw,
packaged raw, unpreserved fish and
unpreserved fish (e.g., frozen, vacuum-
unpasteurized, cooked fishery products
packaged fish fillets) and frozen, reduced
For refrigerated, reduced oxygen packaged oxygen packaged, unpasteurized, cooked
raw, unpreserved fish (e.g., refrigerated, fishery products (e.g., frozen, vacuum-
vacuum-packaged fish fillets) and refrigerated, packaged, unpasteurized crabmeat, lobster
reduced oxygen packaged, unpasteurized, meat, or crayfish meat), the sole barrier to
cooked fishery products (e.g., refrigerated, toxin formation by C. botulinum type E
vacuum-packaged, unpasteurized crabmeat, and non-proteolytic types B and F during
lobster meat, or crayfish meat), the sole finished product storage and distribution
barrier to toxin formation by C. botulinum is freezing. Because these products may
type E and non-proteolytic types B and appear to the retailer, consumer, or end user
F during finished product storage and to be intended to be refrigerated, rather than
distribution is refrigeration. These types of C. frozen, labeling to ensure that they are held
botulinum will grow at temperatures as low frozen throughout distribution is critical to
as 38°F (3.3°C). As was previously noted, their safety.
maintenance of temperatures below 38°F
(3.3°C) after the product leaves your control Controls should be in place to ensure that
and enters the distribution system cannot such products are immediately frozen after
normally be ensured. The use of a TTI on processing, maintained frozen throughout
the smallest unit of packaging (i.e., the unit storage in your facility, and labeled to
of packaging that will not be distributed be held frozen and to be thawed under
any further, usually consumer or end-user refrigeration immediately before use (e.g.,
package) may be an appropriate means of “Important, keep frozen until used, thaw
overcoming these problems in the distribution under refrigeration immediately before use”).
system. This chapter provides controls for the Frozen, reduced oxygen packaged products
application of TTIs for packaging. that are customarily cooked by the consumer
or end user in the frozen state (e.g., boil-in
If you intend to package these products in bag products and frozen fish sticks) need not
a reduced oxygen package and you do not be labeled to be thawed under refrigeration.
intend to apply a TTI on each consumer For purposes of hazard analysis, other frozen
package, you should evaluate the effectiveness products that do not contain the “keep
of other preventive measures, either singularly, frozen” statement should be evaluated as if
or in combination, that may be effective in they will be stored refrigerated because the
preventing growth and toxin formation by C. consumer or end user would not have been
botulinum. Such evaluation is customarily warned to keep them frozen.
accomplished by conducting an inoculated
pack study under moderate abuse conditions. Control procedures to ensure that product
A suitable protocol for the performance of is properly labeled with “keep frozen”
such studies is contained in a 1992 publication instructions are covered in this chapter.
by the National Advisory Committee on
Microbiological Criteria for Foods, “Vacuum
or modified atmosphere packaging for
refrigerated, raw fishery products.”
254
• Control in unrefrigerated (shelf-stable), DETERMINE WHETHER THE POTENTIAL
reduced oxygen packaged fishery products HAZARD IS SIGNIFICANT.
Examples of shelf-stable, reduced oxygen
packaged fishery products are dried fish, The following guidance will assist you in
acidified fish, canned fish, and salted fish. determining whether C. botulinum toxin formation
Because these products are marketed without is a significant hazard at a processing step:
refrigeration, either (1) the spores of C.
botulinum types A, B, E, and F should be 1. Is it reasonably likely that C. botulinum will
destroyed after the product is placed in the grow and produce toxin during finished product
finished product container (covered by the storage and distribution?
LACF Regulation, 21 CFR 113) or (2) a barrier, The factors that make C. botulinum toxin
or combination of barriers, should be in place formation during finished product storage
that will prevent growth and toxin formation and distribution reasonably likely to occur
by C. botulinum types A, B, E, and F, and are those that may result in the formation of
other pathogens that may be present in the a reduced oxygen packaging environment.
product. Suitable barriers include: These are discussed in the section
• Adding sufficient salt to produce “Understand the potential hazard,” under the
a water phase salt level (i.e., the heading, “Reduced oxygen packaging.”
concentration of salt in the water
2. Can growth and toxin formation by C. botulinum that
portion of the fish flesh) of at least
is reasonably likely to occur be eliminated or reduced
20%. Note that this value is based on
to an acceptable level at this processing step?
the maximum salt level for growth of
S. aureus, covered in this chapter; C. botulinum toxin formation should also
be considered a significant hazard at any
• Reducing the amount of moisture
processing step where a preventive measure
that is available for growth (water
is, or can be, used to eliminate the hazard
activity) to below 0.85 (e.g., by adding
(or reduce the likelihood of its occurrence to
salt or other substances that bind the
an acceptable level) if it is reasonably likely
available water). Note that this value
to occur.
is based on the minimum water activity
for growth and toxin formation of S. Preventive measures for C. botulinum toxin
aureus, covered in this chapter; formation during finished product distribution
and storage are discussed in the section,
• Adding sufficient acid to reduce the pH
“Understand the potential hazard,” under the
to 4.6 or below. This barrier is covered
heading, “Control of C. botulinum.”
by the Acidified Foods regulation, 21 CFR
114, and these controls are not required • Intended use
to be included in your HACCP plan;
Because of the extremely toxic nature of
• Drying the product sufficiently to C. botulinum toxin, it is unlikely that the
reduce the water activity to 0.85 or significance of the hazard will be affected by the
below. Note that this value is based intended use of your product.
on the minimum water activity for
growth and toxin formation of S.
aureus, covered in Chapter 14.
Note: A heat treatment, addition of chemical additives, or
other treatment may be necessary to inhibit or eliminate
spoilage organisms (e.g., mold) in shelf-stable products.
255
IDENTIFY CRITICAL CONTROL POINTS. • Products dried to control the
growth of C. botulinum type E
The following guidance will assist you in and non-proteolytic types B and
determining whether a processing step is a F and refrigerated to control the
critical control point (CCP) for C. botulinum toxin growth of C. botulinum type A and
formation: proteolytic types B and F and other
pathogens that may be present.
1. Is there an acidification step (equilibrium pH
In these cases, you should also identify
of 4.6 or below), a drying step, an in-package
the finished product storage step as
pasteurization step, a combination of cook and
a CCP for the hazard. Control of
hot-fill steps, or a retorting step (commercial
refrigeration is covered in this chapter for
sterility) in the process?
C. botulinum and in Chapter 12 for other
a. If there is, you should in most cases pathogenic bacteria.
identify the acidification step, drying Additionally, some pasteurized surimi
step, pasteurization step, cook and hot- based products rely on a combination of
fill steps, or retorting step as the CCP(s) salt and a relatively mild pasteurization
for this hazard. Other processing steps process in the finished product container
where you have identified C. botulinum for the control of C. botulinum type E
toxin formation as a significant hazard and non-proteolytic types B and F. In
will then not require control and will these products, you should also identify
not need to be identified as CCPs for the formulation step as a CCP for the
the hazard. However, control should hazard. Guidance provided in “Control
be provided for time and temperature Strategy Example 4 - Pickling and Salting”
exposure during finished product may be useful in developing controls at
storage and distribution of the following this step.
products:
Guidance for the C. botulinum control
• Products pasteurized in the final strategies listed above is contained in the
container to kill C. botulinum type following locations:
E and non-proteolytic types B
• Control of cooking and hot-filling
and F and refrigerated to control
is covered in Chapters 16 and 18;
the growth of C. botulinum type
A and proteolytic types B and F • Control of pasteurization is
and other pathogens that may covered in Chapters 16 and 18;
be present (e.g., pasteurized
• Control of drying is covered
crabmeat and pasteurized surimi);
in Chapter 14;
• Products cooked to kill C. botulinum
• Control of acidification is
type E and non-proteolytic types
covered in the Acidified Foods
B and F, and then hot filled into
regulation, 21 CFR 114;
the final container, and next
refrigerated to control the growth • Control of retorting is covered in
of C. botulinum type A and the LACF Regulation, 21 CFR 113.
proteolytic types B and F and other Note: Acidification and retorting controls for C. botulinum
pathogens that may be present; required by 21 CFRs 113 and 114 need not be included
in your HACCP plan.
256
b. If there is no acidification step and the smoking step should be identified as
(equilibrium pH of 4.6 or below), drying a CCP for this hazard. The smoking step for
step, pasteurization step, cooking and hot-smoked fish should be sufficient to damage
hot-filling, or retorting (commercial the spores and make them more susceptible to
sterility) step in the process, then decide inhibition by salt. The smoking step for cold-
which of the following categories best smoked fish should not be so severe that it kills
describes your product and refer to the the natural spoilage bacteria. These bacteria
guidance below: are necessary so that the product will spoil
before toxin production occurs. It is likely
• Smoked and smoke-flavored fish;
that they will also produce acid, which will
• Fishery products in which further inhibit C. botulinum growth and toxin
refrigeration is the sole barrier formation.
to prevent toxin formation;
This control approach is a control strategy
• Fishery products in which freezing is referred to in this chapter as “Control Strategy
the sole barrier to toxin formation; Example 1 - Smoking (1b - Cold Smoking and
1c - Hot Smoking).”
• Pickled fish and similar products.
3. Is the storage temperature important to the safety
• Smoked and smoke-flavored fish
of the product?
1. Is the water phase salt level and, when permitted,
the nitrite level, important to the safety of the Refrigerated (not frozen) finished product
product? storage is critical to the safety of all products
in this category and should be identified as
For all products in this category, the water a CCP. Toxin formation by C. botulinum
phase salt level is critical to the safety of the type A and proteolytic types B and F is not
product, and the brining, dry salting and, inhibited by water phase salt levels below
where applicable, drying steps should be 10%, nor by the combination of inhibitors
identified as CCPs. Nitrite, when permitted, present in most smoked or smoke-flavored
allows a lower level of salt to be used. Salt fish. Bacillus cereus can grow and form
and nitrite are the principal inhibitors to toxin at water phase salt concentrations as
C. botulinum type E and non-proteolytic high as 18%.
types B and F toxin formation in these
products. The water phase salt level needed
referred to in this chapter as “Control Strategy
to inhibit toxin formation is partially achieved
Example 1 - Smoking (1d - Refrigerated
during brining or dry salting and is partially
Finished Product Storage).”
achieved during drying. Control should be
exercised over both operations. In some cases, salted, smoked, or smoke-
flavored fish are received as ingredients
for assembly into another product, such
as a salmon paté. In other cases, they are
Example 1 - Smoking (1a - Brining, Dry
received simply for storage and further
Salting, and Drying).”
distribution (e.g., by a warehouse). In either
2. Is the temperature of the heating or smoking case, the refrigerated (not frozen) storage step
process important to the safety of the product? is critical to the safety of the product and
should be identified as a CCP. Control is the
For both cold-smoked and hot-smoked fish
same as that provided under “Control Strategy
products, the temperature of smoking is critical,
Example 1 - Smoking (1d - Refrigerated
257
Finished Product Storage).” Additionally, This control approach is a control strategy
receiving of these products should be referred to in this chapter as “Control Strategy
identified as a CCP, where control can be Example 2 - Refrigeration With a TTI (2e
exercised over the time and temperature Receipt of Product by Secondary Processor).”
during transit.
As previously noted, maintenance of
This control approach is a control strategy temperatures below 38°F (3.3°C) after the
referred to in this chapter as “Control product leaves your control and enters the
Strategy Example 1 - Smoking (1e - Receipt of distribution system cannot normally be
Products by Secondary Processor).” ensured. The use of a TTI on the smallest
unit of packaging (i.e., the unit of packaging
• Fishery products in which refrigeration is that will not be distributed any further,
the sole barrier to prevent toxin formation
usually consumer or end-user package) may
1. Is the storage temperature important to the safety be an appropriate means of overcoming these
of the product? problems in the distribution system. When
TTIs are used in this manner, their receipt,
Refrigerated finished product storage is
storage, and application and activation should
critical to the safety of all products in this
be identified as CCPs.
category and should be identified as a CCP.
These products contain no barriers (other This control approach is a control strategy
than refrigeration) to toxin formation by C. referred to as “Control Strategy Example 2
botulinum type E and non-proteolytic types Refrigeration With TTI (2a - Unactivated TTI
B and F during finished product storage and Receipt, 2b - Unactivated TTI Storage, and 2c
distribution. These types of C. botulinum - Application and Activation of TTI).”
will grow at temperatures as low as 38°F
• Fishery products in which freezing is the
(3.3°C), necessitating particularly stringent
sole barrier to toxin formation
temperature control.
1. Is the storage temperature important to the safety
of the product?
Example 2 - Refrigeration With TTI (2d Frozen finished product storage is critical to
Refrigerated Finished Product Storage).” the safety of all products in this category.
These products contain no barriers (other
In some cases, these products are received as
than freezing) to toxin formation by C.
ingredients for assembly into another product.
botulinum type E and non-proteolytic types
In other cases, they are received simply for
B and F during finished product storage and
storage and further distribution (e.g., by a
distribution. As previously noted, because
warehouse). In either case, the refrigerated
these products may appear to the retailer,
storage step is critical to the safety of the
consumer, or end user to be intended to be
product and should be identified as a CCP.
refrigerated, rather than frozen, labeling to
Control is the same as that provided under
ensure that they are held frozen throughout
“Control Strategy Example 2 - Refrigeration
distribution is critical to their safety and
With a TTI (2d - Refrigerated Finished
should be identified as a CCP.
Product Storage).” Additionally, receiving of
these products should be identified as a CCP, This control approach is a control strategy
where control can be exercised over the time referred to in this chapter as “Control Strategy
and temperature during transit. Example 3 - Frozen With Labeling.”
258
• Pickled and salted fish and similar products Salting (4b - Refrigerated Finished Product
1. Is the water phase salt level, water activity, and/ Storage).” Additionally, receiving of these
or pH level important to the safety of the product? products should be identified as a CCP,
where control can be exercised over time and
For all products in this category, the water temperature during transit.
phase salt level, water activity, and/or pH
level are critical to the safety of the product
because they are the principal inhibitors to
Example 4 - Pickling and Salting (4c - Receipt
growth and toxin formation by C. botulinum
of Product by Secondary Processor).”
type E and non-proteolytic type B and F. The
levels of these inhibitors needed to inhibit
toxin formation are achieved during the DEVELOP A CONTROL STRATEGY.
pickling, brining, or formulation step. Control
should be exercised over the relevant step. The following guidance provides four control
strategies for C. botulinum toxin formation. You
This control approach is a control strategy may select a control strategy that is different from
referred to in this chapter as “Control Strategy those which are suggested, provided it complies
Example 4 - Pickling and Salting (4a - with the requirements of the applicable food
Brining, Pickling, Salting, and Formulation).” safety laws and regulations. Control strategies
2. Is the storage temperature important to the safety contain several elements that may need to be
of the product? used in combination to result in an effective
control program.
Unless pickling, brining, or formulation results
The following are examples of control strategies
in a water phase salt level of at least 20%
included in this chapter:
(note that this value is based on the maximum
salt concentration for growth of S. aureus), a MAY APPLY TO MAY APPLY TO
pH of 4.6 or below, or a water activity of 0.85 CONTROL STRATEGY PRIMARY SECONDARY
PROCESSOR PROCESSOR
or below (note that this value is based on
Smoking  
the minimum water activity for growth of S.
aureus), refrigerated finished product storage Refrigeration with TTI  
is critical to ensure the safety of the product Frozen with labeling  
and should be identified as a CCP. Pickling and salting  
referred to in this chapter as “Control Strategy • CONTROL STRATEGY EXAMPLE 1 - SMOKING
Example 4 - Pickling and Salting (4b This control strategy should include the following
Refrigerated Finished Product Storage).” elements, as appropriate:
In some cases, pickled fish or similar a. Brining, dry salting, and drying;
products are received as ingredients
for assembly into another product. In b. Cold smoking;
other cases, they are received simply for
c. Hot smoking;
storage and further distribution (e.g., by a
warehouse). In either case, the refrigerated d. Refrigerated finished product storage;
storage step is critical to the safety of the
product and should be identified as a CCP. e. Receipt of products by secondary
Control is the same as that provided under processor.
“Control Strategy Example 4 - Pickling and
259
1A. BRINING, DRY SALTING, AND DRYING • Monitor brine temperature at
the start of the brining process
Set Critical Limits.
with a temperature- indicating
• The minimum or maximum values for the device (e.g., a thermometer),
critical factors of the brining, dry salting, and then monitor ambient air
and/or drying processes established by a temperature using a continuous
scientific study. The critical factors are those temperature-recording device
that are necessary to ensure that the finished (e.g., a recording thermometer);
product has not less than 3.5% wps or, where
AND
permitted, the combination of 3% wps and

not less than 100 ppm nitrite. The critical ° Monitor the drying time and the input/
factors may include: brine strength; brine to output air temperature (as specified
fish ratio; brining time; brining temperature; by the study) using a continuous
thickness, texture, fat content, quality, and temperature-recording device (e.g., a
species of fish; drying time; input/output air recording thermometer);
temperature, humidity, and velocity; smoke AND
density; and drier loading.
° Monitor all other critical factors specified
by the study with equipment appropriate
Establish Monitoring Procedures. for the measurement;
» What Will Be Monitored? OR
• The critical factors of the established brining, • Collect a representative sample of the
dry salting, and/or drying processes. These finished product and conduct water phase
may include: brine strength; brine to fish salt analysis and, when appropriate, nitrite
ratio; brining time; brining temperature; analysis.
thickness, texture, fat content, quality, and
species of fish; drying time; input/output air » How Often Will Monitoring Be Done (Frequency)?
temperature, humidity, and velocity; smoke • For brine strength:
density; and drier loading;
° At least at the start of the brining
OR process;
• The water phase salt and, where appropriate, AND
nitrite level of the finished product. • For brine time:

» How Will Monitoring Be Done? ° Once per batch;
• For monitoring critical factors: AND
° Monitor brine strength with a • For manual brine temperature monitoring:
salinometer;
° At the start of the brining process and at

AND
least every 2 hours thereafter;
° Monitor brine time with a clock;

AND
AND
• For continuous temperature-recording
devices:
° Monitor brine temperature using:
• A temperature-indicating device
° Continuous monitoring by the device
itself, with a visual check of the recorded
(e.g., a thermometer); data at least once per batch;
OR
260
AND that is not hermetically sealed, or an LACF,
• For brine to fish ratio: or a frozen product);
° At the start of the brining process; OR

AND • Destroy the product;
• For time requirements of the drying process: OR
° Each batch; • Divert the product to a non-food use.
AND AND
• For all other critical factors specified by the Take the following corrective action to regain control
study: over the operation after a critical limit deviation:
° As often as necessary to maintain control; • Adjust the salt and/or nitrite concentration in
OR the brine;
• For water phase salt and, when appropriate, OR
nitrite: • Adjust the air velocity or input air
° Each lot or batch of finished product. temperature to the drying chamber;
» Who Will Do the Monitoring? OR

• For continuous temperature-recording • Extend the drying process to compensate
devices: for a reduced air velocity or temperature or
elevated humidity;
° Monitoring is performed by the device
itself. The visual check of the data OR
generated by the device, to ensure • Adjust the brine strength or brine to fish ratio;
that the critical limits have been met
consistently, may be performed by any OR
person who has an understanding of the • Cool the brine;
nature of the controls; OR
OR • Move some or all of the product to another
• For other checks: drying chamber;
° Any person who has an understanding of OR

the nature of the controls. • Make repairs or adjustments to the drying
chamber as necessary.
Establish Corrective Action Procedures.
Take the following corrective action to a product Establish a Recordkeeping System.
involved in a critical limit deviation: • Printouts, charts, or readings from continuous
• Chill and hold the product until its safety can temperature-recording devices;
be evaluated; AND
OR • Record of visual checks of recorded data;
• Reprocess the product; AND
OR • Appropriate records (e.g., processing record
• Divert the product to a use in which the showing the results of the brine strength
critical limit is not applicable (e.g., packaging and temperature, brine to fish ratio, size
261
and species of fish, and time of brining) as applicable, nitrite levels should be
necessary to document the monitoring of taken into consideration in the process
the critical factors of the brining, dry salting, establishment. A record of the process
and/or drying process, as established by a establishment should be maintained;
study;
AND
OR • Before a temperature-indicating device (e.g.,
• Results of the finished product water phase a thermometer) or temperature-recording
salt determination and, when appropriate, device (e.g., a recording thermometer) is
nitrite determination. put into service, check the accuracy of the
device to verify that the factory calibration
Establish Verification Procedures. has not been affected. This check can be
• Process validation study (except where water accomplished by:
phase salt analysis and, where appropriate, ° Immersing the sensor in an ice slurry
nitrite analysis of the finished product are the (32°F (0°C)), if the device will be used at
monitoring procedure): or near refrigeration temperature;
° The adequacy of the brining, dry OR
salting, and drying processes should
be established by a scientific study. It ° Immersing the sensor in boiling water
(212°F (100°C)) if the device will be used
should be designed to consistently at or near the boiling point. Note that
achieve a water phase salt level of the temperature should be adjusted to
3.5% or 3% with not less than 100 ppm compensate for altitude, when necessary;
nitrite. Expert knowledge of salting and/
or drying processes may be required OR
to establish such a process. Such ° Doing a combination of the above if
knowledge can be obtained by education the device will be used at or near room
or experience, or both. Process temperature;
validation study for establishment of
OR
brining, dry salting, and drying processes
may require access to adequate facilities ° Comparing the temperature reading
and the application of recognized on the device with the reading on a
methods. The drying equipment should known accurate reference device (e.g.,
be designed, operated, and maintained to a thermometer traceable to National
deliver the established drying process to Institute of Standards and Technology
every unit of product. In some instances, (NIST) standards) under conditions that
brining, dry salting, and/or drying studies are similar to how it will be used (e.g.,
may be required to establish minimum air temperature, brine temperature,
processes. In other instances, existing product internal temperature) within the
literature, which establishes minimum temperature range at which it will be
processes or adequacy of equipment, used;
is available. Characteristics of the AND
process, product, and/or equipment • Once in service, check the temperature-
that affect the ability of the established indicating device or temperature-recording
minimum salting, dry salting, and drying device daily before the beginning of
process to deliver the desired finished operations. Less frequent accuracy checks
product water phase salt and, where may be appropriate if they are recommended
262
by the instrument manufacturer and the and verification records within 1 week of
history of use of the instrument in your preparation to ensure they are complete and
facility has shown that the instrument any critical limit deviations that occurred
consistently remains accurate for a longer were appropriately addressed.
period of time. In addition to checking that
1B. COLD SMOKING
the device is accurate by one of the methods
described above, this process should include Set Critical Limits.
a visual examination of the sensor and any
• The smoker temperature must not exceed
attached wires for damage or kinks. The
90°F (32.2°C).
device should be checked to ensure that it
is operational and, where applicable, has
Establish Monitoring Procedures.
sufficient ink and paper;
AND » What Will Be Monitored?
• Calibrate the temperature-indicating device • The smoker temperature.
or temperature recording device against a » How Will Monitoring Be Done?
known accurate reference device (e.g., a
• Measure ambient smoker chamber
NIST-traceable thermometer) at least once a
temperature using a continuous temperature-
year or more frequently if recommended by
recording device (e.g., a recording
the device manufacturer. Optimal calibration
thermometer).
frequency is dependent upon the type,
condition, past performance, and conditions » How Often Will Monitoring Be Done (Frequency)?
of use of the device. Consistent temperature • Continuous monitoring by the device itself,
variations away from the actual value (drift) with a visual check of the recorded data at
found during checks and/or calibration may least once per batch.
show a need for more frequent calibration or
the need to replace the device (perhaps with » Who Will Do the Monitoring?
a more durable device). Devices subjected • Monitoring is performed by the device itself.
to high temperatures for extended periods of The visual check of the data generated
time may require more frequent calibration. by the device, to ensure that the critical
Calibration should be performed at a limits have been met consistently, may
minimum of two temperatures that bracket be performed by any person who has an
the temperature range at which it is used; understanding of the nature of the controls.
AND
• Perform other calibration procedures as
necessary to ensure the accuracy of the Take the following corrective action to a product
monitoring instruments; involved in a critical limit deviation:
AND • Chill and hold the product until its safety can
be evaluated;
• Do finished product sampling and analysis
to determine water phase salt and, where OR
appropriate, nitrite analysis at least once • Divert the product to a use in which the
every 3 months (except where such testing is critical limit is not applicable (e.g., packaging
performed as part of monitoring); that is not hermetically sealed, or an LACF,
AND or a frozen product);
• Review monitoring, corrective action, OR
263
• Destroy the product; traceable thermometer) under conditions
that are similar to how it will be used (e.g.,
OR
air temperature) within the temperature
• Divert the product to a non-food use. range at which it will be used;
AND AND
Take the following corrective action to regain control • Once in service, check the temperature-
over the operation after a critical limit deviation: recording device daily before the beginning
• Make repairs or adjustments to the smoking of operations. Less frequent accuracy checks
chamber; may be appropriate if they are recommended
by the instrument manufacturer and the
AND/OR
history of use of the instrument in your
• Move some or all of the product to another facility has shown that the instrument
smoking chamber. consistently remains accurate for a longer
Establish a Recordkeeping System. the device is accurate by one of the methods
• Printouts, charts, or readings from continuous described above, this process should include
temperature-recording devices; a visual examination of the sensor and any
AND
device should be checked to ensure that it
• Record of visual checks of recorded data. is operational and, where applicable, has
sufficient ink and paper;
Establish Verification Procedures.
AND
• Before a temperature-recording device (e.g.,
a recording thermometer) is put into service, • Calibrate the temperature-recording device
check the accuracy of the device to verify that against a known accurate reference device
the factory calibration has not been affected. (e.g., a NIST-traceable thermometer) at
This check can be accomplished by: least once a year or more frequently if
recommended by the device manufacturer.
° Immersing the sensor in an ice slurry
Optimal calibration frequency is dependent
(32°F (0°C)) if the device will be used at
upon the type, condition, past performance,
or near refrigeration temperature;
and conditions of use of the device.
OR Consistent temperature variations away from
the actual value (drift) found during checks
° Immersing the sensor in boiling water
(212°F (100°C)) if the device will be used and/or calibration may show a need for more
at or near the boiling point. Note that frequent calibration or the need to replace
the temperature should be adjusted to the device (perhaps with a more durable
compensate for altitude, when necessary; device). Calibration should be performed at
a minimum of two temperatures that bracket
OR
the temperature range at which it is used;
° Doing a combination of the above if
AND
the device will be used at or near room
temperature; • Review monitoring, corrective action,
and verification records within 1 week of
OR
preparation to ensure they are complete and
° Comparing the temperature reading on any critical limit deviations that occurred
the device with the reading on a known were appropriately addressed.
accurate reference device (e.g., a NIST-
264
1C. HOT SMOKING OR
Set Critical Limits. • Destroy the product;
• The internal temperature of the fish must OR

be maintained at or above 145°F (62.8°C) • Divert the product to a non-food use.
throughout the fish for at least 30 minutes. AND
Establish Monitoring Procedures. Take the following corrective action to regain control
over the operation after a critical limit deviation:
» What Will Be Monitored? • Make repairs or adjustments to the heating
• The internal temperature at the thickest chamber;
portion of three of the largest fish in the
OR
smoking chamber.
• Move some or all of the product to another
» How Will Monitoring Be Done? heating chamber.
• Use a continuous temperature-recording
device (e.g., a recording thermometer) Establish a Recordkeeping System.
equipped with three temperature-sensing • Printouts, charts, or readings from continuous
probes. temperature-recording devices;
» How Often Will Monitoring Be Done (Frequency)? AND
• Continuous monitoring by the device itself, • Record of visual checks of recorded data.
with visual check of the recorded data at
least once per batch. Establish Verification Procedures.
» Who Will Do the Monitoring?
a recording thermometer) is put into service,
• Monitoring is performed by the device itself. check the accuracy of the device to verify
The visual check of the data generated that the factory calibration has not been
by the device, to ensure that the critical affected. This check can be accomplished
limits have been met consistently, may by:
be performed by any person who has an
understanding of the nature of the controls. ° Immersing the sensor in an ice slurry
or near refrigeration temperature;
OR
Take the following corrective action to a product
involved in a critical limit deviation: ° Immersing the sensor in boiling water
(212°F (100°C)) if the device will be used
• Chill and hold the product until its safety can
at or near the boiling point. Note that
be evaluated;
the temperature should be adjusted to
OR compensate for altitude, when necessary;
• Reprocess the product; OR
OR ° Doing a combination of the above if
• Divert the product to a use in which the the device will be used at or near room
critical limit is not applicable (e.g., packaging temperature;
that is not hermetically sealed, or a LACF, or OR
a frozen product);
265
° Comparing the temperature reading on preparation to ensure they are complete and
the device with the reading on a known any critical limit deviations that occurred
accurate reference device (e.g., a NIST- were appropriately addressed.
traceable thermometer) under conditions
1D. REFRIGERATED FINISHED PRODUCT STORAGE
product internal temperature) within the Set Critical Limits.
temperature range at which it will be used;
• For refrigerated (not frozen) finished product
AND storage:
• Once in service, check the temperature- ° The product is held at a cooler
recording device daily before the beginning temperature of 40°F (4.4°C) or

of operations. Less frequent accuracy checks below. Note that allowance for routine
may be appropriate if they are recommended refrigeration defrost cycles may be
by the instrument manufacturer and the necessary. Also note that you may
history of use of the instrument in your choose to set a critical limit that specifies
facility has shown that the instrument a time and temperature of exposure to
consistently remains accurate for a longer temperatures above 40°F (4.4°C);
OR
described above, this process should include • For finished product stored under ice:
a visual examination of the sensor and any ° The product is completely and
attached wires for damage or kinks. The continuously surrounded by ice
device should be checked to ensure that it throughout the storage time.
is operational and, where applicable, has
sufficient ink and paper; Establish Monitoring Procedures.
AND » What Will Be Monitored?
• Calibrate the temperature-recording device • For refrigerated finished product storage:
against a known accurate reference device
(e.g., a NIST-traceable thermometer) at ° The temperature of the cooler;
least once a year or more frequently if OR

recommended by the device manufacturer. • For finished product storage under ice:
° The adequacy of ice surrounding the
product.
Consistent temperature variations away from » How Will Monitoring Be Done?
the actual value (drift) found during checks • For refrigerated finished product storage:
and/or calibration may show a need for more
frequent calibration or the need to replace ° Use a continuous temperature-recording
device (e.g., a recording thermometer);
the device (perhaps with a more durable
device). Calibration should be performed at OR
a minimum of two temperatures that bracket • For finished product storage under ice:
° Make visual observations of the
AND adequacy of ice in a representative
number of containers (e.g., cartons and
• Review monitoring, corrective action,
totes) from throughout the cooler.
266
» How Often Will Monitoring Be Done (Frequency)? OR
• For continuous temperature-recording ° Move some or all of the product in the
devices: malfunctioning cooler to another cooler;
° Continuous monitoring by the device OR
itself, with a visual check of the recorded

data at least once per day; ° Freeze the product;
AND
OR
• Address the root cause:
• For finished product storage under ice:
° Make repairs or adjustments to the
° Sufficient frequency to ensure control. malfunctioning cooler;
• For continuous temperature-recording
devices:
° Make adjustments to the ice application
operations.
itself. The visual check of the data Establish a Recordkeeping System.
generated by the device, to ensure • For refrigerated finished product storage:
consistently, may be performed by any ° Printouts, charts, or readings from
continuous temperature-recording
person who has an understanding of the

devices;
nature of the controls;

AND
OR
• For other checks: ° Record of visual checks of recorded data;
OR
° Any person who has an understanding of
the nature of the controls. • For finished product storage under ice:
° Results of ice checks:
• The number of containers examined
Take the following corrective action to a product and the sufficiency of ice for each;
involved in a critical limit deviation:
AND
• Chill and hold the affected product until an
evaluation of the total time and temperature • The approximate number of
exposure is performed; containers in the cooler.
OR Establish Verification Procedures.

• Destroy the product; • Before a temperature-recording device (e.g.,
OR a recording thermometer) is put into service,
• Divert the product to a non-food use. check the accuracy of the device to verify that
the factory calibration has not been affected.
AND This check can be accomplished by:
Take the following corrective actions to regain control ° Immersing the sensor in an ice slurry
over the operation after a critical limit deviation: (32°F (0°C)) if the device will be used at
• Prevent further deterioration: or near refrigeration temperature;
° Add ice to the product; OR
267
° Comparing the temperature reading on of fish to ensure that the ice is sufficient
the device with the reading on a known to maintain product temperatures at 40°F
accurate reference device (e.g., a NIST- (4.4°C) or less;
traceable thermometer) under conditions
AND
air temperature) within the temperature • Review monitoring, corrective action,
range at which it will be used; and verification records within 1 week of
AND any critical limit deviations that occurred
• Once in service, check the temperature- were appropriately addressed.
recording device daily before the beginning
1E. RECEIPT OF PRODUCTS BY SECONDARY
of operations. Less frequent accuracy checks
PROCESSOR
may be appropriate if they are recommended
by the instrument manufacturer and the Set Critical Limits.
history of use of the instrument in your
• For fish or fishery products delivered
facility has shown that the instrument
refrigerated (not frozen):
consistently remains accurate for a longer
period of time. In addition to checking that ° All lots received are accompanied by
the device is accurate by one of the methods transportation records that show that
described above, this process should include the product was held at or below 40°F
a visual examination of the sensor and any (4.4°C) throughout transit. Note that
attached wires for damage or kinks. The allowance for routine refrigeration
device should be checked to ensure that it defrost cycles may be necessary;
is operational and, where applicable, has OR
sufficient ink and paper; • For products delivered under ice:
AND
° Product is completely surrounded by ice
• Calibrate the temperature-recording device at the time of delivery;
against a known accurate reference device OR
(e.g., a NIST-traceable thermometer) at

• For products delivered under chemical
least once a year or more frequently if
cooling media, such as gel packs:
Optimal calibration frequency is dependent ° There is an adequate quantity of cooling
upon the type, condition, past performance, media that remain frozen to have
and conditions of use of the device. maintained product at 40°F (4.4°C) or
Consistent temperature variations away from below throughout transit;
the actual value (drift) found during checks AND
frequent calibration or the need to replace ° The internal temperature of the product
at the time of delivery is 40°F (4.4°C) or
below;
device). Calibration should be performed at
a minimum of two temperatures that bracket OR
the temperature range at which it is used; • For products delivered refrigerated (not
AND frozen) with a transit time (including all
time outside a controlled temperature
• When visual checks of ice are used,
environment) of 4 hours or less (optional
periodically measure internal temperatures
control strategy):
268
° Time of transit does not exceed 4 hours; containers (e.g., cartons and totes) at the
time of delivery.
AND
° Temperature of the product at the time » How Will Monitoring Be Done?
of delivery does not exceed 40°F (4.4°C). • For products delivered refrigerated (not
Note: Processors receiving product with transit times of 4 hours or less frozen):
may elect to use one of the controls described for longer transit times.
° Use a continuous temperature-recording
device (e.g., a recording thermometer)
Establish Monitoring Procedures. for internal product temperature or
» What Will Be Monitored? ambient air temperature monitoring
during transit;
• For products delivered refrigerated (not
frozen): OR
• For products delivered under ice:
° The internal temperature of the product
throughout transportation; ° Make visual observations of the
OR adequacy of ice in a representative
number of containers (e.g., cartons and
° The temperature within the truck or
totes) from throughout the shipment, at
other carrier throughout transportation;
delivery;
OR
OR
• For products delivered under ice:
• For products delivered under chemical
° The adequacy of ice surrounding the cooling media, such as gel packs:
product at the time of delivery;
° Make visual observations of the

OR
adequacy and frozen state of the cooling
• For products held under chemical cooling media in a representative number of
media, such as gel packs: containers (e.g., cartons and totes) from
throughout the shipment, at delivery;
° The quantity and frozen status of cooling
media at the time of delivery; AND
AND ° Use a temperature-indicating device (e.g.,
a thermometer) to determine internal
° The internal temperature of a
product temperatures in a representative
representative number of product
containers (e.g., cartons and totes) at number of product containers from
time of delivery; throughout the shipment, at delivery;
OR OR
• For products delivered refrigerated (not • For products delivered refrigerated (not
frozen) with a transit time of 4 hours or less: frozen) with a transit time of 4 hours or less:
° The date and time fish were removed ° Review carrier records to determine
from a controlled temperature the date and time the product was
environment before shipment and the removed from a controlled temperature
date and time delivered; environment before shipment and the
date and time delivered;
AND
AND
° The internal temperature of a
representative number of product
269
° Use a temperature-indicating device (e.g., • Discontinue use of the supplier or carrier
a thermometer) to determine internal until evidence is obtained that the identified
product temperatures in a representative transportation-handling practices have been
number of product containers (e.g., improved.
cartons and totes) randomly selected
from throughout the shipment, at Establish a Recordkeeping System.
delivery. Measure a minimum of 12 • Receiving records showing:
product containers, unless there are
fewer than 12 product containers in a ° Results of continuous temperature
monitoring:
lot, in which case measure all of the
containers. Lots that show a high level • Printouts, charts, or readings
of temperature variability may require a from continuous temperature-
larger sample size. recording devices;
» How Often Will Monitoring Be Done (Frequency)? AND

• Each lot received. • Visual check of recorded data;
• For continuous temperature-recording ° Results of ice checks, including:
devices: • The number of containers examined

and the sufficiency of ice for each;
itself. The visual check of the data AND
generated by the device, to ensure
• The number of containers in the lot;

consistently, may be performed by any OR
person who has an understanding of the ° Results of the chemical media checks,
nature of the controls; including:

OR • The number of containers
• For other checks: examined and the frozen status
of the media for each;
° Any person who has an understanding of
the nature of the controls. AND
AND/OR
involved in a critical limit deviation: ° Results of internal product temperature
monitoring, including:
• Chill and hold the affected product until an
• The number of containers
evaluation of the total time and temperature
examined and the internal
exposure is performed;
temperatures observed for each;
OR
AND
• Reject the lot.
AND
AND
Take the following corrective action to regain control
• Date and time fish were initially
removed from a controlled
270
temperature environment recommended by the device manufacturer.
and date and time fish were Optimal calibration frequency is dependent
delivered, when applicable. upon the type, condition, past performance,
Establish Verification Procedures. Consistent temperature variations away from
• Before a temperature-indicating device (e.g., the actual value (drift) found during checks
a thermometer) is put into service, check and/or calibration may show a need for more
the accuracy of the device to verify that the frequent calibration or the need to replace
factory calibration has not been affected. the device (perhaps with a more durable
This check can be accomplished by: device). Calibration should be performed at
(32°F (0°C)), if the device will be used at
or near refrigeration temperature; AND
OR • Check the accuracy of temperature-recording
° Comparing the temperature reading on devices that are used for monitoring transit
the device with the reading on a known conditions, for all new suppliers and at
accurate reference device (e.g., a NIST- least quarterly for each supplier thereafter.
traceable thermometer) under conditions Additional checks may be warranted based
that are similar to how it will be used on observations at receipt (e.g., refrigeration
(e.g., product internal temperature) units appear to be in poor repair or readings
within the temperature range at which it appear to be erroneous). The accuracy of
will be used; the device can be checked by comparing
the temperature reading on the device with
AND
the reading on a known accurate reference
• Once in service, check the temperature- device (e.g., a NIST-traceable thermometer)
indicating device daily before the under conditions that are similar to how it
beginning of operations. Less frequent will be used (e.g., air temperature) within the
accuracy checks may be appropriate if temperature range at which it will be used;
they are recommended by the instrument
manufacturer and the history of use of AND
the instrument in your facility has shown • When visual checks of ice are used,
that the instrument consistently remains periodically measure internal temperatures
accurate for a longer period of time. In of fish to ensure that the ice or is sufficient
addition to checking that the device is to maintain product temperatures at 40°F
accurate by one of the methods described (4.4°C) or less;
above, this process should include a AND
visual examination of the sensor and any
device should be checked to ensure that
it is operational;
any critical limit deviations that occurred
AND were appropriately addressed.
• Calibrate the temperature-indicating device
271
TABLE 13-1
CONTROL STRATEGY EXAMPLE 1 - SMOKING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Smoking.” This example illustrates how a processor of vacuum-packaged hot-
smoked salmon can control C. botulinum toxin formation. It is provided for illustrative purposes only.
C. botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g.,
aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, survival of other pathogenic bacteria through the
cook step, and metal fragments).
Example Only
See Text for Full Recommendations
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL LIMITS MONITORING

CRITICAL
SIGNIFICANT FOR EACH CORRECTIVE
CONTROL RECORDS VERIFICATION
HAZARD(S) PREVENTIVE WHAT HOW FREQUENCY WHO ACTION(S)
POINT
MEASURE*
Brining C. botulinum Minimum Start time Clock Every batch Brine Extend the Production Establish
toxin brining time: and end time room brining record a brining and
formation in 6 hours of the brining Dial Every 2 hours employee process drying process
the finished process thermometer
product Maximum brine Hold and evaluate Check the dial thermometer for
272
temperature: 40ºF Brine the product accuracy and damage and to
temperature Cool the brine ensure that it is operational
before putting into operation;
Minimum salt Salt Salinometer Start of each Brine Add salt Production
check it daily, at the beginning of
concentration of concentration brining room record
operations; and calibrate it once
brine at the start of brine process employee
per year
of brining: 60°
salinometer
Monthly calibration of the scale

Minimum ratio of Weight of Visual, to Start of each Brine Add brine Production
brine to fish: brine (as mark on the brining room record Quarterly water phase salt analysis
2:1 determined tank process employee of the finished product
by volume)
Review monitoring, corrective
action, and verification records
Weight of Scale Each batch Remove some fish
within 1 week of preparation
fish and reweigh
Maximum fish Fish Caliper Each batch Brine Hold and evaluate Production
thickness 1½ in. thickness (10 largest room based on finished record
Note: To produce fish) employee product water
a minimum water phase salt analysis
phase salt level in
the loin muscle of
3.5%
TABLE 13-1
CONTROL STRATEGY EXAMPLE 1 - SMOKING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Smoking.” This example illustrates how a processor of vacuum-packaged hot-
smoked salmon can control C. botulinum toxin formation. It is provided for illustrative purposes only.
aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, survival of other pathogenic bacteria through the
cook step, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE*
Smoking C. botulinum Minimum time Time of open Clock Each batch Smoker Extend the drying Production Establish a brining and drying
and toxin open vent: 2 hours vent employee process record process Quarterly water phase salt
drying formation Hold and evaluate analysis of the finished product
in finished based on finished Review monitoring, corrective
product product water action, and verification records
273
phase salt analysis within 1 week of preparation
Heating C. botulinum Internal Internal Digital data Continuous, Smoker Extend the Data Check the data logger for accuracy
toxin temperature of fish temperature logger with with visual employee heating logger and damage and to ensure that
formation in held at or above of fish and three probes check of process printout it is operational before putting
the finished 145°F for at least 30 time at that in thickest recorded data Make repairs or into operation; check it daily, at
product minutes temperature fish in cold at the end of adjustments to the the beginning of operations; and
spot of the batch smoking chamber calibrate it once per year
smoking Review monitoring, corrective

chamber Hold and evaluate action, and verification records
the product within 1 week of preparation

Finished C. botulinum Maximum cooler Cooler air Digital data Continuous, Production Adjust or repair Digital Check the data logger for accuracy
product toxin temperature: 40°F temperature logger with visual employee the cooler data logger and damage and to ensure that
storage formation (based on growth check of Hold and evaluate printout it is operational before putting
during of vegetative recorded data the product based into operation; check it daily, at
finished pathogens) once per day on time and the beginning of operations; and
product temperature of calibrate it once per year
storage exposure
Review monitoring, corrective
action, and verification records
within 1 week of preparation
*Note: The critical limits in this example are for illustrative purposes only and are not related to any recommended process.
• CONTROL STRATEGY EXAMPLE 2 - ° Performance data from the manufacturer;
REFRIGERATION WITH TTI
AND
This control strategy should include the following • For transportation conditions:
elements, as appropriate:
° The temperature within the truck or
a. Unactivated TTI receipt; other carrier throughout transportation;
b. Unactivated TTI storage; OR
c. Application and activation of TTI;

° Other conditions that affect the
functionality of the TTI, where
applicable;
d. Refrigerated finished product storage;
AND
e. Receipt of product by secondary
• For functionality at receipt:

processor.
° The ability of the TTI to produce an

2A. UNACTIVATED TTI RECEIPT alert indicator, such as a color change of
the device, when exposed to time and
temperature abuse at time of receipt.
• The TTI is suitable for use. It should be
designed to perform properly under the » How Will Monitoring Be Done?
conditions that it will be used. It should • For suitability of use:
also be designed to produce an alert ° Review performance data;
indicator (e.g., a color change of the device)
AND
at a combination of time and temperature
exposures that will prevent the formation of • For transportation conditions:
non-proteolytic C. botulinum toxin formation ° Use a continuous temperature-recording
(e.g., consistent with the “Skinner-Larkin device (e.g., a recording thermometer)
curve”); for ambient air temperature monitoring
during transit;
AND
• Where transportation conditions (e.g., AND
temperature) could affect the functionality • For functionality at receipt:
of the TTI, all lots of TTIs are accompanied
by transportation records that show that they
° Activate and then expose a TTI from
the lot to ambient air temperature for
were held at conditions that do not result in sufficient time to determine whether
loss of functionality throughout transit; it is functional (i.e., produces an alert
AND indicator, such as a color change of the
device).
• The TTI functions (i.e., produces an
alert indicator, such as a color change of » How Often Will Monitoring Be Done (Frequency)?
the device, when exposed to time and • For suitability of use:
temperature abuse) at time of receipt.
° The first shipment of a TTI model;
Establish Monitoring Procedures. AND
• For transportation conditions and
» What Will Be Monitored?
functionality at receipt:
• For suitability of use:

° Every shipment.
274
» Who Will Do the Monitoring? ° Records of visual checks of recorded
• For suitability of use: data;
° Anyone with an understanding of TTI AND
validation studies and of the intended • For functionality at receipt:

conditions of use;
° Results of a TTI challenge test (i.e.,
AND whether the TTI produces an alert
• For transportation conditions and indicator, such as a color change of
functionality at receipt: the device, when exposed to time and
temperature abuse).
° Anyone with an understanding of the
nature of the controls.
Establish Corrective Action Procedures. • Check the accuracy of temperature-recording
devices that are used for monitoring transit
Take the following corrective action to a product conditions, for all new suppliers and at
involved in a critical limit deviation: least quarterly for each supplier thereafter.
• Reject or return the shipment. Additional checks may be warranted based
AND on observations at receipt (e.g., refrigeration
units appear to be in poor repair or readings
Take the following corrective actions to regain control appear to be erroneous). The accuracy of
over the operation after a critical limit deviation: the device can be checked by comparing
• For suitability of use: the temperature reading on the device with
the reading on a known accurate reference
° Discontinue use of the supplier until
device (e.g., a NIST-traceable thermometer)
documentation of validation has been
provided; under conditions that are similar to how it
will be used (e.g., air temperature) within the
AND
temperature range at which it will be used;
• For transportation conditions and
functionality at receipt: AND
° Discontinue use of the supplier or
carrier until evidence is obtained that the
identified production or transportation preparation to ensure they are complete and
practices have been improved. any critical limit deviations that occurred
were appropriately addressed.
Establish a Recordkeeping System. 2B. UNACTIVATED TTI STORAGE
• For suitability of use: Set Critical Limits.
° Manufacturer’s performance data;
• The combination of storage conditions
AND (e.g., temperature) that prevent loss of
• For transportation conditions: functionality throughout storage (based
on manufacturer’s specifications).
° Printouts, charts, or readings from
continuous temperature-recording
devices;
AND
275
Establish Monitoring Procedures. Establish Corrective Action Procedures.
» What Will Be Monitored? Take the following corrective action to a TTI involved in a
critical limit deviation:
• Storage air temperature, where temperature
affects functionality of the TTI; • Destroy the lot of TTIs.
AND/OR AND
• Other storage conditions that affect Take the following corrective action to regain control
functionality of the TTI. over the operation after a critical limit deviation:
• Make repairs or adjustments to the
» How Will Monitoring Be Done?
malfunctioning cooler;
• For temperature:
AND/OR
° Use a continuous temperature-recording
• Make other repairs or adjustment appropriate
device (e.g., a recording thermometer);
for the condition.
AND/OR
• For other conditions: Establish a Recordkeeping System.
° Use instruments appropriate for the • For refrigerated storage:
purpose.
° Printouts, charts, or readings from
» How Often Will Monitoring Be Done (Frequency)? continuous temperature-recording
devices;
• For temperature:
AND
° Continuous monitoring by the device

itself, with a visual check of the recorded ° Record of visual checks of recorded data;
data at least once per day;

AND/OR
AND/OR • Storage record showing the results of
• For other conditions: monitoring of other conditions.
° With sufficient frequency to ensure
control. Establish Verification Procedures.
a recording thermometer) is put into service,
• With continuous temperature-recording check the accuracy of the device to verify that
devices: the factory calibration has not been affected.
° Monitoring is performed by the device This check can be accomplished by:
itself. The visual check of the data
generated by the device, to ensure
that the critical limits have been met or near refrigeration temperature;
consistently, may be performed by any
person who has an understanding of the OR
nature of the controls; ° Comparing the temperature reading on
the device with the reading on a known
AND
accurate reference device (e.g., a NIST-
• For other checks: traceable thermometer) under conditions
° Any person who has an understanding of that are similar to how it will be used (e.g.,
the nature of the controls. air temperature) within the temperature
range at which it will be used;
276
AND 2C. APPLICATION AND ACTIVATION OF TTI
• Once in service, check the temperature- Set Critical Limits.
recording device daily before the beginning
of operations. Less frequent accuracy checks • Each consumer package has an activated
may be appropriate if they are recommended TTI.
by the instrument manufacturer and the
history of use of the instrument in your Establish Monitoring Procedures.
facility has shown that the instrument
consistently remains accurate for a longer
• Packages for the presence of an activated
TTI.
described above, this process should include » How Will Monitoring Be Done?
a visual examination of the sensor and any
• Visual examination.
device should be checked to ensure that it » How Often Will Monitoring Be Done (Frequency)?
is operational and, where applicable, has • Representative number of packages from
sufficient ink and paper; each lot of product.
AND
• Calibrate the temperature-recording device
• Any person who has an understanding of the
Optimal calibration frequency is dependent Take the following corrective action to a product
upon the type, condition, past performance, involved in a critical limit deviation:
and conditions of use of the device. • Hold the lot below 38°F (3.3°C) until TTIs
Consistent temperature variations away from are applied and activated.
and/or calibration may show a need for more AND
frequent calibration or the need to replace Take the following corrective action to regain control
the device (perhaps with a more durable over the operation after a critical limit deviation:
device). Calibration should be performed at • Identify and correct the cause of the TTI
a minimum of two temperatures that bracket application or activation deficiency.
AND Establish a Recordkeeping System.
• Perform other instrument calibration, as • Packaging control record that shows the
appropriate; results of the TTI checks.
AND
• Review monitoring and corrective action
records within 1 week of preparation
to ensure they are complete and any
any critical limit deviations that occurred
critical limit deviations that occurred were
were appropriately addressed.
appropriately addressed.
277
2D. REFRIGERATED FINISHED PRODUCT STORAGE
Follow the guidance for “Control Strategy
Example 1 - Smoking (1d - Refrigerated Finished
Product Storage),” except that the where the
critical limits list 40ºF (4.4ºC), they should list
38°F (3.3°C).
2E. RECEIPT OF PRODUCTS BY SECONDARY

PROCESSOR
Follow the guidance for “Control Strategy
Example 1 - Smoking (1e - Receipt of Products
by Secondary Processor),” except that the where
the critical limits list 40ºF (4.4ºC), they should list
38°F (3.3°C).
278
TABLE 13-2
CONTROL STRATEGY EXAMPLE 2 - REFRIGERATION WITH TTI

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Refrigeration With TTI.” This example illustrates how a processor of refrigerated,
vacuum-packaged, raw fish fillets can control C. botulinum toxin formation. It is provided for illustrative purposes only.
C. Botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g.,
aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
SIGNIFICANT FOR EACH
CONTROL CORRECTIVE ACTION(S) RECORDS VERIFICATION
HAZARD(S) PREVENTIVE WHAT HOW FREQUENCY WHO
POINT
MEASURE
Receipt of C. botulinum TTI is Performance Review of First Quality Reject the Manufacturer’s Review
TTI toxin suitable for use data from the performance shipment of a assurance shipment performance monitoring,
formation in manufacturer data TTI model supervisor Discontinue use of the data corrective
the finished supplier until appropriate action records
product validation within 1 week
documentation of preparation
279
is provided
All lots received Truck Digital time and Continuous, Receiving Discontinue use of the Receiving Check the data
are temperature temperature with visual employee supplier or carrier until record logger for all
accompanied data logger review and evidence is obtained new suppliers
by truck evaluation of that the identified and for all
records temperature- transportation- handling suppliers at
that show monitoring practices have been least quarterly
temperature records for each improved thereafter

was maintained shipment
at or below Reject the Review
40°F shipment monitoring,
corrective
action records
within 1 week
of preparation
The TTI The ability Expose a TTI Every Quality Discontinue use of the TTI Review
functions of the TTI to from the lot shipment assurance supplier or carrier until challenge monitoring,
at receipt change color to room air staff evidence is obtained that record corrective
when exposed temperature for the identified production action records
to room air sufficient time or transportation- within 1 week
temperature to determine handling practices have of preparation
whether it been improved
changes color
TABLE 13-2

Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
TTI C. botulinum Cooler Cooler Digital time and Continuous, Quality Repair or adjust cooler Data Check the
storage toxin maintained temperature temperature with visual assurance logger printout data logger for
formation in below 38°F data logger check of staff Destroy the lot of TTIs accuracy and
the finished recorded data damage and to
product once per day ensure that it
is operational
280
before putting
into operation;
check it
daily, at the
beginning of
operations; and
calibrate it once
per year

Review
monitoring,
corrective
action, and
verification
records within
1 week of
preparation
TTI C. botulinum Each Packages for Visual Representative Production Hold lot below 38°F, and Packaging Review
attachment toxin package has an the presence examination number of employee apply and activate TTIs control record monitoring,
and formation in activated TTI of an packages from and corrective
activation the finished activated TTI each lot of Identify and correct the action and
product product cause of TTI application verification
deviation records within
1 week of
preparation
TABLE 13-2

Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
Finished C. botulinum Maximum Cooler air Digital data Continuous, Production Adjust or repair cooler Digital logger Check the
product toxin cooler temperature logger with visual employee printout data logger for
storage formation temperature check of Hold and accuracy and
during 38°F recorded data evaluate the product damage and to
finished once per day based on time and ensure that it
product temperature of exposure is operational
281
storage before putting
into operation;
check it
daily, at the
beginning of
operations; and
calibrate it once
per year

Review
monitoring,
corrective
action, and
verification
records within
1 week of
preparation
*Note: The critical limits in this example are for illustrative purposes only and are not related to any recommended process.
• CONTROL STRATEGY EXAMPLE 3 - FROZEN WITH Establish Verification Procedures.
LABELING • Review monitoring and corrective action
Set Critical Limits. records within 1 week of preparation
to ensure they are complete and any
• All finished product labels must contain a
critical limit deviations that occurred were
“keep frozen” statement (e.g., “Important,
appropriately addressed.
keep frozen until used, thaw under
refrigeration immediately before use”).
Establish Monitoring Procedures.

• Finished product labels for the presence of a
“keep frozen” statement.

• Visual examination.
» How Often Will Monitoring Be Done (Frequency)?

• Representative number of packages from
each lot of product.

• Any person who has an understanding of the

• Segregate and relabel any improperly labeled
product.
AND
Take the following corrective actions to regain control
• Segregate and return or destroy any label
stock or pre-labeled packaging stock that
does not contain the proper statement;
AND
• Determine and correct the cause of improper
labels.
Establish a Recordkeeping System.

• Record of labeling checks.
282
TABLE 13-3
CONTROL STRATEGY EXAMPLE 3 - FROZEN WITH LABELING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Frozen With Labeling.” This example illustrates how a processor of frozen,
environmental chemical contaminants and pesticides, parasites, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Receipt of C. botulinum All finished Finished Visual Representative Receiving Segregate and Label receiving Review
labeling toxin product labels product examination number of employee relabel any record monitoring and
283
formation must contain a labels for the packages from improperly correction
during “keep presence of a each lot of labeled product action records
finished frozen” “keep frozen” product within 1 week
product statement statement Segregate and of preparation
storage destroy any
label stock
that does not
contain the

proper
statement
Determine
and correct
the cause of
improper labels
• CONTROL STRATEGY EXAMPLE 4 - PICKLING For unrefrigerated (shelf-stable), reduced oxygen-
AND SALTING packaged products:
This control strategy should include the following ° A water phase salt level of at least 20%
elements, as appropriate: (based on the maximum salt level for
growth of S. aureus);
a. Brining, pickling, salting, and
formulation;
OR
b. Refrigerated finished product storage;

° A pH of 4.6 or below;
OR
c. Receipt of Product by secondary
processor.
° A water activity of 0.85 or below (based

on the minimum water activity for
growth and toxin formation of S. aureus).
4A. BRINING, PICKLING, SALTING, AND
FORMULATION A heat treatment, addition of chemical additives,
or other treatment may be necessary to inhibit or
eliminate spoilage organisms (e.g., mold) in shelf-
• The minimum or maximum values for stable products.
the critical factors of the brining, pickling,
or formulation process established by a Establish Monitoring Procedures.
scientific study. The critical factors are those
that are necessary to ensure that the finished » What Will Be Monitored?
product has: • The critical factors of the established
pickling, brining, or formulation process.
For refrigerated, reduced oxygen-packaged
These may include: brine and acid strength;
fishery products:
brine or acid to fish ratio; brining and
° A water phase salt level of at least 5%; pickling time; brine and acid temperature;
OR
thickness, texture, fat content, quality, and
species of fish;
° A pH of 5.0 or below;
OR
OR
• The water phase salt, pH, and/or water
° A water activity of below 0.97;
activity of the finished product.

OR
° A water phase salt level of at least
2.4% in surimi-based products, when
• For brine strength:
combined with a pasteurization process
° Use a salinometer;
in the finished product container
AND
of 185°F (85°C) for 15 minutes
(pasteurization controls are covered in

• For acid strength:
Chapter 16);
° Use a pH meter or titrate for acid
concentration;
OR
AND
° A combination of water phase salt,
pH, and/or water activity that, when • For brine/acid temperature:

combined, have been demonstrated to
prevent the growth of C. botulinum type
° Use a temperature-indicating device (e.g.,
a thermometer);
E and non-proteolytic types B and F.

AND
284
• For all other critical factors specified by the Establish Corrective Action Procedures.
study:
° Use equipment appropriate for the
measurement;
• Chill and hold the product until it can be

OR
evaluated based on its water phase salt, pH,
• For water phase salt, pH, and/or water and/or water activity level;
activity:
OR
° Collect a representative sample of the
• Reprocess the product (if reprocessing does
finished product, and conduct water
not jeopardize the safety of the product);
phase salt, pH, and/or water activity
analysis, as appropriate. OR
• Divert the product to a use in which the
» How Often Will Monitoring Be Done (Frequency)?
critical limit is not applicable (e.g., packaging
• For brine and acid strength: that is not hermetically sealed, or a LACF, or
° At the start of each brining, pickling, and a frozen product);
formulation process;
OR
AND
• Divert the product to a non-food use;
• For brine and acid temperature:
OR
° At the start of each brining, pickling, and
• Destroy the product.
formulation process and at least every 2
hours thereafter; AND
AND Take the following corrective action to regain control
• For brine or acid to fish ratio: over the operation after a critical limit deviation:
• Adjust the brine or acid strength or brine or
° At the start of each brining, pickling, and
acid to fish ratio;
formulation process;
AND
OR
• For other critical factors specified by the study: • Extend the brining or pickling time to
compensate for an improper brine or acid
° As often as necessary to maintain control;
temperature.
OR
• Water phase salt, pH, and/or water activity Establish a Recordkeeping System.
analysis should be determined for each batch • Records, as necessary, to document the
of finished product. monitoring of the critical factors of the
brining or pickling process, as established
by a study (e.g., a processing record showing
• For water activity: the results of the brine or acid strength
° Any person with sufficient training to and temperature, brine or acid to fish ratio,
perform the analysis;
size and species of fish, time of brining or
pickling);
OR
• For other checks: OR

• Record of determinations of the finished
° Any person with an understanding of the
product water phase salt, pH, or water activity.
285
Establish Verification Procedures. and/or product that affect the ability
• Process validation study (except where water of the established minimum pickling,
phase salt, pH, or water activity analysis brining, and formulation process
of the finished product is the monitoring should be taken into consideration in
procedure): the process establishment. A record of
the process establishment should be
° The adequacy of the pickling, brining,
maintained;
and formulation process steps should
be established by a scientific study. For AND
refrigerated, reduced oxygen-packaged • Before a temperature-indicating device (e.g.,
products, it should be designed to a thermometer) is put into service, check
consistently achieve: a water phase salt the accuracy of the device to verify that the
level of at least 5%; a pH of 5.0 or below; factory calibration has not been affected.
a water activity of below 0.97; a water This check can be accomplished by:
phase salt level of at least 2.4% in surimi
based products, when combined with
a pasteurization process in the finished or near refrigeration temperature;
product container of 185°F (85°C) for
at least 15 minutes; or a combination OR
of salt, pH, and/or water activity that, ° Immersing the sensor in boiling water
when combined, prevent the growth of (212°F (100°C)) if the device will be
C. botulinum type E and non-proteolytic used at or near the boiling point. Note
types B and F (established by a scientific that the temperature should be adjusted
study). For unrefrigerated (shelf-stable), to compensate for altitude, when
reduced oxygen-packaged products, necessary);
it should be designed to consistently OR
achieve: a water phase salt level of
at least 20% (based on the maximum ° Doing a combination of the above if
the device will be used at or near room
water phase salt level for the growth of
temperature;
S. aureus); a pH of 4.6 or below; or a
water activity of 0.85 or below (based OR
on the minimum water activity for the
growth of S. aureus). Expert knowledge
° Comparing the temperature reading on
the device with the reading on a known
of pickling, brining, and formulation accurate reference device (e.g., a NIST-
processes may be required to establish traceable thermometer) under conditions
such a process. Such knowledge can be that are similar to how it will be used
obtained by education or experience, or (e.g., brine temperature) within the
both. Establishment of pickling, brining, temperature range at which it will be
and formulation processes may require used;
access to adequate facilities and the
application of recognized methods. In AND
some instances, pickling, brining, and • Once in service, check the temperature-
formulation studies may be required to indicating device daily before the beginning
establish minimum processes. In other of operations. Less frequent accuracy checks
instances, existing literature, which may be appropriate if they are recommended
establishes minimum processes, is by the instrument manufacturer and the
available. Characteristics of the process history of use of the instrument in your
286
facility has shown that the instrument any critical limit deviations that occurred
consistently remains accurate for a longer were appropriately addressed.
4B. REFRIGERATED FINISHED PRODUCT STORAGE
described above, this process should include Follow the guidance for “Control Strategy
a visual examination of the sensor and any Example 1 - Smoking (1d - Refrigerated Finished
attached wires for damage or kinks. The Product Storage).”
device should be checked to ensure that it is
4C. RECEIPT OF PRODUCT BY SECONDARY
operational;
PROCESSOR
AND Follow the guidance for “Control Strategy
• Calibrate the temperature-indicating device Example 1 - Smoking (1e - Receipt of Product by
against a known accurate reference device Secondary Processor).”
Consistent temperature variations away from
frequent calibration or the need to replace
device). Calibration should be performed at
AND
• Perform daily calibration of pH meters
against standard buffers;
AND
• Perform other calibration procedures as
necessary to ensure the accuracy of the
monitoring instruments;
AND
• Do finished product sampling and analysis
to determine water phase salt, pH, or water
activity level, as appropriate, at least once
every 3 months (except where such testing is
performed as part of monitoring);
AND
287
TABLE 13-4
CONTROL STRATEGY EXAMPLE 4 - PICKLING AND SALTING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Pickling and Salting.” This example illustrates how a pickled herring processor
can control C. botulinum toxin formation. It is provided for illustrative purposes only.
histamine, environmental and chemical contaminants and pesticides, parasites, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
Pickling C. botulinum Maximum Finished Collect a Each Quality Continue the Pickling control Daily calibration of
toxin formation finished product pH in sample of the pickling control pickling process record the pH meter
in the finished product pH in the loin muscle product from tank, each personnel until pH meets Review
product the loin muscle each pickling cycle the critical limit monitoring,
of 5.0 tank at the corrective action,
end of each and verification
288
pickling cycle records within
and analyze for 1 week of
pH using a pH preparation
meter
Finished C. botulinum Maximum Cooler air Time and Continuous, Production Adjust or Data logger Check the data
product storage toxin cooler temperature temperature with visual employee repair cooler printout logger for accuracy
formation temperature: data logger check of and damage and
during 40°F recorded Hold and to ensure that

finished (based on data once evaluate the it is operational
product growth of per day product based before putting
storage vegetative on time and into operation;
pathogens) temperature of check it daily, at
exposure the beginning of
operations; and
calibrate it once
per year
Review
monitoring,
corrective action,
and verification
records within 1
week of
preparation
BIBLIOGRAPHY. • Daniels, R. W. 1991. Applying HACCP to
new-generation refrigerated foods at retail
We have placed the following references on and beyond. Food Technol. 45:122, 124.
display in the Division of Dockets Management, • Dufresne, I., J. P. Smith, J. N. Liu, and I. Tarte.
Food and Drug Administration, 5630 Fishers Lane, 2000. Effect of films of different oxygen
rm. 1061, Rockville, MD 20852. You may see transmission rate on toxin production by
them at that location between 9 a.m. and 4 p.m., Clostridium botulinum type E in vacuum
Monday through Friday. As of March 29, 2011, packaged cold and hot smoked trout fillets. J.
FDA had verified the Web site address for the Food Saf. 20:251-268.
references it makes available as hyperlinks from • Eklund, M. W., G. A. Pelroy, R. Paranjpye, M.
the Internet copy of this guidance, but FDA is not E. Peterson, and F. M. Teeny. 1982. Inhibition
responsible for any subsequent changes to Non- of Clostridium botulinum types A and E
FDA Web site references after March 29, 2011. toxin production by liquid smoke and NaCl
in hot-process smoke-flavored fish. J. Food
• Association of Food and Drug Officials. 2005. Prot. 44:935-941.
Cured, salted, & smoked fish establishments • Essuman, K. M., 1992. Fermented fish in
good manufacturing practices, including Africa: a study on processing marketing and
Listeria Control Manual. Association of Food consumption. FAO Fisheries technical paper no.
and Drug Officials, York, PA. T329. FAO, Rome, Italy. ISBN: 9251032556. 80p.
• Baird-Parker, A. C., and B. Freame. 1967. • European Chilled Food Federation. 1997.
Combined effect of water activity, pH and Guidelines for good hygienic practice in the
temperature on the growth of Clostridium manufacture of chilled foods. Kettering, NN.
botulinum from spore and vegetative cell • Farber, J. M. 1991. Microbiological aspects of
inocula. J. Appl. Bact. 30:420-429. modified atmosphere packaging technology -
• Betts, G. D., and J. E. Getts. 1995. Growth a review. J. Food Prot. 54:58-70.
and heat resistance of psychotropic • Garren, D. M., M. A. Harrison, and Y. W.
Clostridium botulinum in relation to ‘sous Huang. 1994. Clostridium botulinum type E
vide’ products. Food Control 6:57-63. outgrowth and toxin production in vacuum-
• Boyd, J. W., and B. A. Southcott. 1971. Effects skin packaged shrimp. Food Microbiol.
of sodium chloride on outgrowth and toxin 11:467-472.
production of Clostridium botulinum type • Gould, G. W. 1999. Sous vide foods:
E in cod homogenates. J. Fish. Res. Bd. conclusions of an ECFF botulinum working
Canada. 28:1071-1075. party. Food Control 10:47-51.
• Brody, A. L. (ed.). 1989. Controlled/modified • Graham, A. F., D. R. Mason, and M. W.
atmosphere/vacuum packaging of foods. Peck. 1996. Predictive model of the effect
Food and Nutrition Press, Inc., Trumbull, CT. of temperature, pH and sodium chloride
• Crisan, E.V., and A. Sands. 1975. Microflora of on growth from spores of non-proteolytic
four fermented fish sauces. Appl. Microbiol. Clostridium botulinum. Int. J. Food Microbiol.
29(1): 106-108. 31:69-85.
• Christiansen, L. N., J. Deffner, E. M. Foster, • Hathaway, C.L. 1993. Clostridium botulinum
and H. Sugiyama. 1968. Survival and and other Clostridia that produce botulinum.
outgrowth of Clostridium botulinum type In Clostridium botulinum Ecology and Control
E spores in smoked fish. Appl. Microbiol. in Foods. A.H.W Hauschild and K.L. Dodds
16:133-137. (eds.), Marcel Dekker, New York. 1993.
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• Hauschild, A. H. W., and R. Hilsheimer. 1979. Food Safety and Inspection Service, U.S.
Effect of salt content and pH on toxigenesis Department of Agriculture, Washington, DC.
by Clostridium botulinum in caviar. J. Food http://www.fsis.usda.gov/OPHS/NACMCF/past/
Prot. 42:245-248. map_ fishery.htm.
• Hilderbrand, K. S. 1992. Fish smoking • Peck, M. W. 1997. Clostridium botulinum and
procedures for forced convection the safety of refrigerated processed foods
smokehouses, Special Report 887. Oregon of extended durability. Trends Food Sci.
State Extension Service, Newport, OR. Technol. 8:186-192.
• Kautter, D. A., P. K. Lynt, T. Lily, and H. M. • Pelroy, G. A, M. W. Eklund, R. N. Paranjpye,
Solomon. 1981. Evaluation of the botulism E. M. Suzuki, and M. E. Peterson. 1982.
hazard from nitrogen-packed sandwiches. J. Inhibition of Clostridium botulinum types A
Food Prot. 44:59-61. and E toxin formation by sodium nitrite and
• Kornacki, J. L., and D. A. Gabis. 1990. sodium chloride in hot process (smoked)
Microorganisms and Refrigeration salmon. J. Food Prot. 45:833-841.
Temperatures. Dairy, Food & Environ. Sanit. • Peterson, M. E., G. A. Pelroy, R. N. Paranjpye,
10:192-195. F. T. Poysky, J. S. Almond, and M. W. Eklund.
• Loha-unchit, K. 1998. How Fish Sauce 1993. Parameters for control of Listeria
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http://www.thaifoodandtravel.com/features/ sodium chloride and packaging method. J.
fishsauce1.html. Food Prot. 56:938-943.
• Lerke, P., and L. Farber. 1971. Heat • Reddy, N. R., A. Paradis, M. G. Roman, H. M.
pasteurization of crab and shrimp from the Solomon, and E. J. Rhodehamel. 1996. Toxin
Pacific coast of the United States: public development by Clostridium botulinum in
health aspects. J. Food Sci. 36:277-279. modified atmosphere-packaged fresh tilapia
fillets during storage. J. Food Sci. 61:632-635.
• Lyon, W. J., and C. S. Reddmann. 2000.
Bacteria associated with processed • Reddy, N. R., D. J. Armstrong, E. J.
crawfish and potential toxin production by Rhodehamel, and D. A. Kautter. 1992. Shelf-
Clostridium botulinum type E in vacuum- life extension and safety concerns about
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12:87-118.
• McClure, P. J., M. B. Cole, and J. P. P. M.
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on growth of Clostridium botulinum. J. Appl. Roman, and E. J. Rhodehamel. 1997. Shelf
Bact. Symp. Suppl. 76:105S-114S. life and toxin development by Clostridium
botulinum during storage in modified
• Moody, M.W., G.J. Flick, R.E. Martin, and A.L.
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• National Advisory Committee on
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Vacuum or modified atmosphere packaging
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refrigerated foods. Dairy Food Sanit. 8:5-7.
• Rhodehamel, E. J. 1992. FDA’s concerns with
sous vide processing. Food Technol. 46:73
76.Rhodehamel, E. J., H. M. Solomon, T.
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Incidence and heat resistance of Clostridium
botulinum type E spores in menhaden
surimi. J. Food Sci. 56:1562-1563, 1592.
• Ross, T., and P. Dalgaard. 2004. Secondary
Models - A3.1.3. Salt, water-phase salt, and
water activity. In R. C. McKellar and L.
Xuewen (ed.), Modeling microbial responses
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• Schmidt, R. V., R. V. Lechowich, and J.
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• Segner, W. P, C. F. Schmidt, and J. K.
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• Skinner, G. E., and J. W. Larkin. 1998.
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• Sobel, J., et al., 2004.Foodborne botulism
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• Sugiyama, H., and K. S. Rutledge. 1978. Failure
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291
NOTES:
292

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CHAPTER 13: Clostridium botulinum Toxin Formation

UNDERSTAND THE POTENTIAL HAZARD. • Controlling the amount of moisture that is

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

Relationship of Water Activity to Water Phase

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

Control is the same as that provided under processor.

“Control Strategy Example 4 - Pickling and

CHAPTER 13: Clostridium botulinum Toxin Formation

permitted, the combination of 3% wps and

• The water phase salt and, where appropriate, AND

nitrite level of the finished product. • For brine time:

° At the start of the brining process and at

° Monitor brine time with a clock;

CHAPTER 13: Clostridium botulinum Toxin Formation

° At the start of the brining process; OR

» Who Will Do the Monitoring? OR

° Any person who has an understanding of OR

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

• The internal temperature of the fish must OR

CHAPTER 13: Clostridium botulinum Toxin Formation

• Once in service, check the temperature- ° The product is held at a cooler

recording device daily before the beginning temperature of 40°F (4.4°C) or

least once a year or more frequently if OR

CHAPTER 13: Clostridium botulinum Toxin Formation

° Continuous monitoring by the device OR

itself, with a visual check of the recorded

person who has an understanding of the

nature of the controls;

OR Establish Verification Procedures.

° Add ice to the product; OR

CHAPTER 13: Clostridium botulinum Toxin Formation

against a known accurate reference device OR

(e.g., a NIST-traceable thermometer) at

CHAPTER 13: Clostridium botulinum Toxin Formation

° Make visual observations of the

CHAPTER 13: Clostridium botulinum Toxin Formation

» How Often Will Monitoring Be Done (Frequency)? AND

» Who Will Do the Monitoring? OR

• For continuous temperature-recording ° Results of ice checks, including:

devices: • The number of containers examined

that the critical limits have been met

nature of the controls; including:

CHAPTER 13: Clostridium botulinum Toxin Formation

CHAPTER 13: Clostridium botulinum Toxin Formation

CONTROL STRATEGY EXAMPLE 1 - SMOKING

CRITICAL LIMITS MONITORING

CHAPTER 13: Clostridium botulinum Toxin Formation

CONTROL STRATEGY EXAMPLE 1 - SMOKING